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NCT02885454 · ClinicalTrials.gov registry record · Phase 1

To Evaluate the Effects of Odalasvir and AL-335 With Simeprevir on the Single-Dose Pharmacokinetics of Ethinylestradiol and Drospirenone in Healthy Female Participants

A Phase 1 study, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT02885454 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 24 participants.

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The verdict

NCT02885454, a Phase 1 study, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the effect of steady-state concentrations of odalasvir (ODV), AL-335 and the combination of the 3-direct-acting anti-viral agents (3-DAA) ODV, AL-335, and simeprevir (SMV) on the single-dose pharmacokinetic (PK) of drospirenone and ethinylestradiol in healthy female participants.

Interventions

  • DRUG Odalasvir (ODV)
  • DRUG Simeprevir (SMV)
  • DRUG Drospirenone/ethinylestradiol
  • DRUG AL-335

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2016-08
Est. Completion 2016-12
Phase Phase 1

Sponsor

Janssen Research & Development

593 total trials

What the Registry Record Tells You About NCT02885454

The ClinicalTrials.gov registry entry for NCT02885454 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Odalasvir (ODV) is the first listed.

NCT02885454 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02885454 about?

NCT02885454 is a clinical study titled "To Evaluate the Effects of Odalasvir and AL-335 With Simeprevir on the Single-Dose Pharmacokinetics of Ethinylestradiol and Drospirenone in Healthy Female Participants". The purpose of this study is to evaluate the effect of steady-state concentrations of odalasvir (ODV), AL-335 and the combination of the 3-direct-acting anti-viral agents (3-DAA) ODV, AL-335, and simeprevir (SMV) on the single-dose pharmacokinetic (PK) of drospirenone and ethinylestradiol in healthy...

What is the current status of trial NCT02885454?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2016-08. Estimated completion is 2016-12.

What interventions are being tested in trial NCT02885454?

The interventions under investigation include: Odalasvir (ODV) (DRUG), Simeprevir (SMV) (DRUG), Drospirenone/ethinylestradiol (DRUG), AL-335 (DRUG).

Who is sponsoring clinical trial NCT02885454?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.